Study Shows Increased Risk When Expectant Mother Takes Zofran.The "Andersen Study" has reported a link between the use of Zofran during pregnancy and birth defects. One of the newest lawsuits filed against GlaxoSmithKline (GSK), the makers of Zofran, has reported that a study named the “Andersen Study” has indicated that the use of the drug during pregnancy may result in an increased risk of birth defects in an unborn child. The complaint, which was filed in the U.S. District Court of the Eastern District of Louisiana under case number 2:15-cv-04399-SM-DEK, alleges that GSK knew of the risk associated with the use of Zofran and failed to inform women across the country of potential side effects.
The Approval of ZofranZofran was approved by the U.S. Food and Drug Administration for use as an anti-emetic. However, the drug was only to be used after chemotherapy and radiation treatments, or after anesthesia. The approval did not indicate that the drug was safe to be prescribed to expectant mothers experiencing morning sickness.
Zofran and Birth DefectsEven though the drug was not approved for expectant mothers, GSK began to market it as such to both the medical community and the public. Zofran was prescribed to countless women across the country. Since they first began their “off-label” marketing campaign, GSK has allegedly received over 200 reports from doctors who informed the company that mothers who took Zofran had given birth to children with birth defects.
Numerous epidemiological studies have investigated the association between prenatal exposure to Zofran and the risk of birth defects in babies. One of these, the “Andersen Study”, found that mothers who took Zofran during their first trimester were more likely to have a child with a congenital heart defect. This is not the only study in which researches have come to this conclusion.
Zofran Birth Defect LawsuitsOver the past two years, more than 60 families have filed a lawsuit against GSK, each alleging that Zofran caused a birth defect in an unborn child. Birth defects listed in the complaints include kidney defects, clubfoot, respiratory distress syndrome, cleft lip, cleft palate, atrial septal defect, transposition of the greater vessels, and ventricular septal defect. In the majority of cases, the child has had to undergo multiple operations to correct the defect. In the most tragic cases, the child died due to their birth defect.
Recently, the U.S. Judicial Panel on MultiDistrict Litigation consolidated all Zofran lawsuits into MDL 2657. The consolidation means that all cases will be overseen by Judge F. Dennis Saylor in Boston, Massachusetts. Both GSK and the plaintiffs were happy with the consolidation.
This consolidation does not prevent others from filing their own lawsuit and the number of complaints is expected to swell over the coming months.